Binge EatingNCT04181957
Effects of LDX on Cognitive Processes and Appetite
A study testing Lisdexamfetamine Dimesylate in people with Binge Eating and Eating Behavior, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
This study will investigate the effect of lisdexamfetamine dimesylate (LDX) on the mediating factors of reward and cognition on appetite. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating, Eating Behavior
- What is being tested?
- Lisdexamfetamine Dimesylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2019to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fluent English speakers
- Be willing to be informed of chance pathological findings from the fMRI scan
- Must have binge-eating symptoms that is measured by a minimum score of 18 on the Binge Eating Scale
- Must have a minimum BMI of 18.5
- Must be below 152.4kg
- Must have clearance from a qualified physician before participating
Who cannot join
- Symptoms or diagnosis of other eating disorders.
- Psychotherapy and/or pharmacotherapy for binge-eating disorder (BED) 3 months before the study, as this will suggest a diagnosis of BED and may influence eating behaviour.
- Metabolic (e.g. metabolic disorder, diabetes), psychological (e.g. depression), substance, or neurological (e.g. epilepsy, headache disorder, multiple sclerosis, traumatic brain injuries) diseases or medication in relation to these diseases
- Intake of any medication that can interfere with the drug or measurements, determined through questionnaires in the screening session
- Current smoking, as it can interfere with appetite
- Current pregnancy or breastfeeding
Show all 22Show fewer
- Not passing a breathalyser test on the morning of testing.
- Food allergies (e.g. peanut allergy, lactose and gluten intolerance) or vegetarian/vegan diet
- Disliking the study lunch to ensure that participants will consume the provided food
- Women will be asked to participate only in weeks when they are not menstruating or in their pre-menstrual week, to avoid hormonal disruption to appetite.
- The following are exclusion criteria are specific to the MRI scanner:
- Non-removable metal object in or on their body, such as: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Left-handed
- Tattoos that are older than 10 years
- Claustrophobia
- Limited temperature perception and/or increased sensitivity to warming of the body
- Pathological hearing ability or an increased sensitivity to loud noises
- Operation less than three months ago
- Simultaneous participation in other studies that involve drug intake or blood sampling
- Acute illness or infection during the last 4 weeks
- Cardiovascular disorders (e.g., hypertrophic cardiomyopathy, long QT syndrome) to ensure medical fitness to participate
- Moderate or severe head injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Lisdexamfetamine Dimesylate on Cognitive, Metabolic, and Reward Processes in Individuals With Binge-eating Symptoms
This study will investigate the effect of lisdexamfetamine dimesylate (LDX) on the mediating factors of reward and cognition on appetite.
Read the detailed description
This study will investigate the specific reward and cognitive mechanisms that mediate the effects of LDX on eating in participants with sub-clinical binge-eating disorder symptoms. A sub-clinical sample will be recruited in line with the Research Domain Criteria Initiative established by the US National Institute of Mental Health which encourages research on dimensions of observable behaviour rather than a categorical, symptom-based approach to the study of mental health. The tendency towards binge-like eating will be modelled using an eating in the absence of hunger paradigm in which participants consume a pasta meal and are then offered the opportunity to consume as many palatable cookies as they like. Reward processes will be assessed by measuring neural and behavioural responses to palatable food pictures using functional Magnetic Resonance Imaging (fMRI). Responses to emotional stimuli will be assessed using the P1vital® Oxford Emotional Test Battery. Impulsive responding will be assessed using the delay discounting task and the stop signal task. Attentional processing will be assessed using the sustained performance task and working memory will be assessed with the n-back task.
- Conditions
- Binge Eating, Eating Behavior
- Being tested
- Placebo oral tablet, Lisdexamfetamine Dimesylate
- Medical subject headings
- Bulimia, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral tabletDrug
Participants take one dose of placebo (lactose) tablet.
Lisdexamfetamine DimesylateDrug
Participants take one 50mg tablet of lisdexamfetamine dimesylate once.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants receive placebo tablet composed of lactose. Receives: Drug: Placebo oral tablet |
| Active | Active comparator | Participants receive a 50mg tablet of lisdexamfetamine dimesylate (LDX) once. Receives: Drug: Lisdexamfetamine Dimesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic food intake
We will examine if LDX has an influence on metabolic food intake using a lab-based food task, in which participants eat as much pasta as they like until they feel comfortably full . Amount eaten will be measured in grams.
Measured: 15 minutes
Hedonic food intake
The effect of LDX on hedonic food intake will be measured via offering a palatable snack of chocolate chip cookies 20 minutes after participants have consumed the pasta. Amount eaten will be measured in grams.
Measured: 15 minutes
Secondary outcomes (11)
fMRI Reward Processes
We will investigate the effect of LDX on neural responses to food stimuli using fMRI, and if/how liking ratings modulate these responses. The participants will perform a food and non-food rating task in the scanner, to measure reward-responses. Participants will view a range (36 each category) of high -and low-calorie food (equally distributed in sweet and savoury), and non-food items (visually matched). All items will be scored for appealing/liking with the use of a button box, varying from 1 (not at all) to 5 (very much). Each item will be presented for 3000ms followed by a fixation cross (500 - 1500ms). (3 x 7 min = 21 min)
Measured: 21 minutes
Ratings
We will determine if LDX administration has an effect on appetite and mood ratings via a visual analogue scale (VAS) in a hungry and sated state. Participants will drag a cursor from 0cm (not at all) to 10cm (most I could imagine) to self-report mood and appetite.
Measured: 20 minutes
Emotional processing
We will determine if LDX modulates emotional processing. The ETB is a computerised battery that comprises the following tasks:
FERT: Faces will appear on a screen ranging in emotions. The participant is instructed to classify each expression as quickly and accurately as possible. Accuracy, response bias, reaction time, and target sensitivity.
ECAT: 60 positive and negative adjectives will be presented for the participant to indicate if they would like to be described as such. Accuracy and reaction times.
EREC: The participants will be asked to recall as many words from the ECAT as can be remembered within a 4-minute period. The number of correct words recalled and respective valence will be measured.
EMEM: Participants will be presented with personality descriptors derived from the ECAT, along with matching novel distractor words. Participants will indicate if the descriptor was presented before. Accuracy, reaction time, response bias, and target sensitivity.
Measured: 35 minutes
Memory
We will investigate the effect of LDX on working memory. To assess working memory and working memory capacity, participants will complete a visuospatial n-back task. The participant is presented with a sequence of circles on a 3x3 grid. The participant is instructed to indicate whether the current circle location matches the location of the circle n trials earlier. In this design, participants will identify if the circle matches the circle 2 and 3 trials back on separate cycles. Participants will complete 70 trials of each n-back condition. This task takes approximately 10 minutes to complete.
Measured: 10 minutes
Attention
We will investigate the effect of LDX on attention. This task is a series of white letters presented on a grey background in random order, modelled on the Conner's Continuous Performance Task. Participants are instructed to press the space bar for every letter except 'X'. Letters will be presented for 900ms. Accuracy and reaction time will be measured. The task duration is 14 minutes.
Measured: 14 minutes
Cognitive inhibition/Impulsivity
We will investigate LDX effect on cognitive control (ie inhibition). Participants will complete the delay-discounting task for money and food. The delay-discounting task measures the extent to which participants are willing to delay the receipt of a reward, in exchange for receiving a higher-value reward, and is generally considered to reflect impulsive behaviour. This task is a monetary discounting task with nine delays ranging from one day to one year. On a screen, participants see the question 'Which would you prefer?', with two choices: £xx now or £xx after a delay (varying from one day to one year), and will be asked to choose between the two. A similar paradigm will be used for food, with questions consisting of food variables instead of money. Questions will require a choice between a smaller amount of food now, and a larger amount later. Area under the curve will be calculated.
Measured: 10 minutes
Motor inhibition/Impulsivity
We will measure the effect of LDX on inhibition using the Stop Signal Task. The stop signal task requires the participant to identify the direction of a circle's location on the screen (i.e., left or right). If, however, the circle is encased in another circle, then the participant is to withhold a response. Successful inhibition, commission errors, and reaction time will be measured.
Measured: 10 minutes
fMRI food reward - activation
We will investigate the activation changes in brain regions associated with reward to food when viewing pictures of food.
When assessing changes in activation we will assess how activity in separate brain regions changes when attending to food pictures compared to when attending to visually-matched non-food pictures.
Measured: 21 minutes
fMRI food reward - functional connectivity
We will investigate the changes in functional connectivity between brain regions associated with reward to food when viewing pictures of food.
When looking at changes in functional connectivity we will assess how the relationship between activity in any two or more brain regions is altered when attending to food pictures compared to when attending to visually-matched non-food pictures.
Measured: 21 minutes
fMRI inhibition - activation
We will investigate the effect of LDX on brain regions associated with cognitive control, during performance of a delay discounting task (Outcome 8). When assessing changes in activation we will assess how activity in separate brain regions changes when making decisions about food compared to when making decisions about money.
Measured: 18 minutes
fMRI inhibition - functional connectivity
We will investigate the changes in functional connectivity between brain regions associated with cognitive control.
When looking at changes in functional connectivity we will assess how the relationship between activity in any two or more brain regions is altered when making decisions about food compared to when making decisions about money.
Measured: 18 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start1 May 2019
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge EatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Counter-balanced, double-blind, placebo-controlled, crossover, within-subject design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Higgs, PhD, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181957
- Sponsor's protocol ID
- IRAS 250510
- Status last verified
- Jan 2019
- First submitted
- 13 Nov 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open access to study protocol and data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lisdexamfetamine Dimesylate on Cognitive, Metabolic, and Reward Processes in Individuals With Binge-eating Symptoms
- ClinicalTrials.gov ID
- NCT04181957
- Acronym / sponsor ID
- IRAS 250510
- Conditions
- Binge Eating, Eating Behavior
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effect of lisdexamfetamine dimesylate (LDX) on the mediating factors of reward and cognition on appetite.
Detailed description
This study will investigate the specific reward and cognitive mechanisms that mediate the effects of LDX on eating in participants with sub-clinical binge-eating disorder symptoms. A sub-clinical sample will be recruited in line with the Research Domain Criteria Initiative established by the US National Institute of Mental Health which encourages research on dimensions of observable behaviour rather than a categorical, symptom-based approach to the study of mental health. The tendency towards binge-like eating will be modelled using an eating in the absence of hunger paradigm in which participants consume a pasta meal and are then offered the opportunity to consume as many palatable cookies as they like. Reward processes will be assessed by measuring neural and behavioural responses to palatable food pictures using functional Magnetic Resonance Imaging (fMRI). Responses to emotional stimuli will be assessed using the P1vital® Oxford Emotional Test Battery. Impulsive responding will be assessed using the delay discounting task and the stop signal task. Attentional processing will be assessed using the sustained performance task and working memory will be assessed with the n-back task.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Counter-balanced, double-blind, placebo-controlled, crossover, within-subject design.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo oral tabletParticipants receive placebo tablet composed of lactose. |
| Active | Active comparator | Drug: Lisdexamfetamine DimesylateParticipants receive a 50mg tablet of lisdexamfetamine dimesylate (LDX) once. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Fluent English speakers
- Be willing to be informed of chance pathological findings from the fMRI scan
- Must have binge-eating symptoms that is measured by a minimum score of 18 on the Binge Eating Scale
- Must have a minimum BMI of 18.5
- Must be below 152.4kg
Key exclusion criteria (22 listed)
- Symptoms or diagnosis of other eating disorders.
- Non-removable metal object in or on their body, such as: heart pace-maker, artificial heart valve, metal prosthesis, implants or splinters, non-removable dental braces
- Left-handed
- Tattoos that are older than 10 years
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo oral tabletParticipants take one dose of placebo (lactose) tablet. | Drug | Placebo |
| Lisdexamfetamine DimesylateParticipants take one 50mg tablet of lisdexamfetamine dimesylate once. | Drug | Active |
Primary outcome
Metabolic food intake
Time frame: 15 minutes
We will examine if LDX has an influence on metabolic food intake using a lab-based food task, in which participants eat as much pasta as they like until they feel comfortably full . Amount eaten will be measured in grams.
Hedonic food intake
Time frame: 15 minutes
The effect of LDX on hedonic food intake will be measured via offering a palatable snack of chocolate chip cookies 20 minutes after participants have consumed the pasta. Amount eaten will be measured in grams.
11 secondary outcomes
fMRI Reward Processes
Time frame: 21 minutes
Ratings
Time frame: 20 minutes
Emotional processing
Time frame: 35 minutes
Memory
Time frame: 10 minutes
Attention
Time frame: 14 minutes
Cognitive inhibition/Impulsivity
Time frame: 10 minutes
Motor inhibition/Impulsivity
Time frame: 10 minutes
fMRI food reward - activation
Time frame: 21 minutes
fMRI food reward - functional connectivity
Time frame: 21 minutes
fMRI inhibition - activation
Time frame: 18 minutes
fMRI inhibition - functional connectivity
Time frame: 18 minutes
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: Yes. Open access to study protocol and data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Higgs, PhD principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lisdexamfetamine Dimesylate in people with Binge Eating and Eating Behavior, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic food intake (time frame: 15 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.